RENDER - The International Magazine for Rendering

Feed Rule Goes into Effect, Compliance Given Six-month Reprieve

By Tina Caparella

After receiving over 400 comments on a proposed 60-day extension of its enhanced feed rule due to go into effect April 27, 2009, the U.S. Food and Drug Administration (FDA) ultimately decided to leave the effective date in place but give renderers an additional six months to comply, until October 26, 2009. The agency stated the extended compliance date would give affected parties time to identify alternative disposal methods for material renderers will not be collecting or rendering. However, FDA is encouraging those who are able to begin complying with the rule to do so as soon as possible. The rule is designed to further reduce the risk of bovine spongiform encephalopathy (BSE) in U.S. cattle.

First proposed in late 2005, FDA released a final rule April 25, 2008, “Substances Prohibited from Use in Animal Food or Feed,” that defines “cattle material prohibited from animal feed,” or CMPAF, and prohibits its use in all animal feed beginning one year after publication in the Federal Register. CMPAF includes:
• brains and spinal cords from cattle 30 months of age or older;
• entire carcasses of cattle not inspected (antemortem) and passed for human consumption
– unless shown to be less than 30 months of age, or
– brain and spinal cord are removed;
• entire carcasses of BSE-positive cattle;
• tallow derived from BSE-positive cattle;
• tallow from CMPAF if containing impurities greater than 0.15 percent;
• mechanically separated beef made from CMPAF.

Tallow for use in ruminant feed is more restrictive than in feed for non-ruminants:
• Tallow must be less than 0.15 percent insoluble impurities for ruminant feed.
• Tallow from CMPAF must have impurities less than 0.15 percent to be used in non-ruminant feed.
• Tallow not derived from CMPAF with impurities greater than 0.15 percent can be fed to non-ruminants.

This new rule is in addition to the feed ban already in place since 1997 that prohibits mammalian proteins in ruminant feed. Compliance with that rule has been close to 100 percent since it was put in place.

In early April 2009, FDA proposed to delay the effective date of its 2008 final rule for 60 days and provided a seven-day comment period. Many comments indicated that certain entities were not adequately prepared to comply with the final rule and that sufficient alternative carcass disposal methods had not been developed. However, the majority of the comments received opposed delaying the effective date due to public and animal health concerns.

Shortly after FDA’s decision to keep the April 27, 2009, effective date but extend compliance by six months, the agency released a final guidance document, “Small Entities Compliance Guide for Renderers – Substances Prohibited from Use in Animal Food or Feed,” to provide direction to renderers on the requirements of the final rule. The document should also help slaughter facilities and farms supplying offal and dead livestock to renderers understand their obligations under the new rule. A copy of the guidance document is available at www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/
GuidanceforIndustry/ucm052449.pdf.

Whether renderers will continue to collect dead stock or CMPAF material will be made on a company-by-company, and oftentimes, location-by-location basis. The National Renderers Association anticipates renderers in heavy cattle areas will continue their services, but that they will now require age verification. Those renderers who do collect prohibited material will also possibly begin charging for the service or increasing existing collection fees, primarily to recoup transportation costs for a product that no longer has any value or can be sold in the marketplace.

As for disposal of the prohibited material, landfilling is being examined as one option but many waste management companies have been confused about whether to consider the material hazardous waste. In April, the Environmental Protection Agency (EPA) put to rest any doubts about the issue by clarifying that CMPAF material, which will consist of primarily brains and spinal cords from cattle 30 months of age or older and the entire carcass of dead stock cattle unless such cattle are shown to be less than 30 months of age, would be considered a solid waste under the Resource Conservation and Recovery Act. Under the act, in order for a solid waste to be hazardous it must either be specifically listed or exhibit a characteristic (ignitable, corrosive, reactive, or toxic). EPA declared that animal mortalities and wastes generated from the slaughter of animals, including CMPAF, are neither listed nor would they likely exhibit a characteristic. EPA is encouraging state agriculture agencies to work very closely with their state environmental/solid waste management agencies to “ensure the most effective, environmentally safe, and economic disposal of these materials.”

It is estimated that alternative disposal will be needed for between 300,000 to 350,000 tons of cattle mortalities annually. The new rule is also expected to divert approximately 15,000 tons of slaughter by-products from being rendered for animal feed use.